OverweightNCT03746977
Effects of WB-EMS and Protein Supplementation on LBM Maintenance During Intended Weight Loss
A study testing Protein, Walking and WB-EMS application in people with Overweight and Obesity, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The present study aimed to determine the effect of different interventions on lean body mass maintenance under weight loss conditions in overweight and obese premenopausal women. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Abdominal Obesity
- What is being tested?
- Protein, Walking and WB-EMS application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jan 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- premenopausal women 25-50 years old
- overweight/obesity (body fat rate equal or higher 30%)
Who cannot join
- medication and diseases affecting muscle and fat metabolism
- pregnant or parturition < 6 months
- any condition or medication that prevent proper physical activity or WB-EMS application
- holidays equal or more than 1 week during the intervention period
- other interventions with impact on the primary and core secondary outcome (i.e. body fat parameters) started during the last year.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics University of Erlangen-Nurnberg
Erlangen, 91052
About this study
Official title: Effects of Whole-body Electromyostimulation (WB-EMS), Physical Activity and Protein Supplementation on Lean Body Mass Maintenance During Caloric Restriction and Physical Activity Induced Weight Loss. A Randomized Controlled Study
The present study aimed to determine the effect of different interventions on lean body mass maintenance under weight loss conditions in overweight and obese premenopausal women. Three study groups were implemented: (1) Protein supplementation (only) group (2) Protein supplementation and walking intervention (3) Protein supplementation, walking and WB-EMS-application. All protocols were applied for 16 week of intervention.
A energy deficit of 500 kcal/d was intended however while group (1) focus consistently on energy restriction (500 kcal/d), in group (2) and (3) a combined physical activity (i.e. walking with a volume representing 250 kcal/d) and energy restriction (250 kcal/d) protocol was applied. Total protein uptake including protein supplementation was calculated to average around 1.2 g/kg body mass per day in groups (1) and 1.5 g/kg body mass/d in group (2) and (3). WB-EMS was applied 1.5x 20 min/week (i.e. each Tuesday and every second Thursday).
Primary study endpoint was LBM as determined by Dual Energy x-Ray Absorptiometry.
- Conditions
- Overweight, Obesity, Abdominal Obesity
- Being tested
- Protein, Walking, WB-EMS application
- Keywords
- exercise, electromyostimulation, protein, weight reduction
- Medical subject headings
- Overweight, Obesity, Obesity, Abdominal, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
Protein supplementation 1.2 or 1.5 g/kg body mass/d
WalkingBehavioural
Walking with a volume corresponding to 250 kcal/d
WB-EMS applicationBehavioural
WB-EMS application 1.5x 20 min/week
| Study group | Role | What they receive |
|---|---|---|
| energy restriction and protein supplementation | Active comparator | Energy restriction of 500 kcal/d and total Protein Uptake (including Supplementation) of 1.2 g/kg body mass/d Receives: Dietary Supplement: Protein |
| Energy restriction, walking and protein | Active comparator | Energy restriction of 250 kcal/d, increased energy consumption by walking (250 kcal/d) and total protein uptake (including supplementation) of 1.5 g/kg body mass/d Receives: Dietary Supplement: Protein; Behavioral: Walking |
| Energy restriction, walking, protein and WB-EMS | Active comparator | Energy restriction of 250 kcal/d, increased energy consumption by walking (250 kcal/d), total protein uptake (including supplementation) of 1.5 g/kg body mass/d and WB-EMS application 1,5x 20 min/week Receives: Dietary Supplement: Protein; Behavioral: Walking; Behavioral: WB-EMS application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass
Fat and bone free total body mass in kg
Measured: changes from baseline to 16 week follow-up
Secondary outcomes (6)
Total Body Fat
Total Body Fat in kg
Measured: changes from baseline to 16 week follow-up
Total Body Fat Rate
Percent Total Body Fat Rate
Measured: changes from baseline to 16 week follow-up
Appendicular Skeletal Muscle Mass
Lean Body Mass of the upper and lower limbs in kg
Measured: changes from baseline to 16 week follow-up
Visceral Body Fat
Total visceral body fat in kg
Measured: changes from baseline to 16 week follow-up
Trunk fat
Total trunk fat in kg
Measured: changes from baseline to 16 week follow-up
Metabolic Syndrome Z-Score
Summarized Z-Score that included Z-Scores of blood lipids, lipoproteins, glucose, resting blood pressure and waist circumference. Cut-offs based on the definition of the International Diabetes Federations
Measured: changes from baseline to 16 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start25 Jan 2018
- Primary completion30 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled parallel group design with 3 study arms
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
- Investigators
- Simon von Stengel, PhD, Study chair, Institute of Medical Physics, FAU Erlangen-Nürnberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746977
- Sponsor's protocol ID
- WREPP
- Status last verified
- Mar 2019
- First submitted
- 13 Nov 2018
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-body Electromyostimulation (WB-EMS), Physical Activity and Protein Supplementation on Lean Body Mass Maintenance During Caloric Restriction and Physical Activity Induced Weight Loss. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03746977
- Acronym / sponsor ID
- WREPP
- Conditions
- Overweight, Obesity, Abdominal Obesity
- Keywords
- exercise, electromyostimulation, protein, weight reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aimed to determine the effect of different interventions on lean body mass maintenance under weight loss conditions in overweight and obese premenopausal women. Three study groups were implemented: (1) Protein supplementation (only) group (2) Protein supplementation and walking intervention (3) Protein supplementation, walking and WB-EMS-application. All protocols were applied for 16 week of intervention.
A energy deficit of 500 kcal/d was intended however while group (1) focus consistently on energy restriction (500 kcal/d), in group (2) and (3) a combined physical activity (i.e. walking with a volume representing 250 kcal/d) and energy restriction (250 kcal/d) protocol was applied. Total protein uptake including protein supplementation was calculated to average around 1.2 g/kg body mass per day in groups (1) and 1.5 g/kg body mass/d in group (2) and (3). WB-EMS was applied 1.5x 20 min/week (i.e. each Tuesday and every second Thursday).
Primary study endpoint was LBM as determined by Dual Energy x-Ray Absorptiometry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled parallel group design with 3 study arms
| Arm | Type | Receives |
|---|---|---|
| energy restriction and protein supplementation | Active comparator | Dietary Supplement: ProteinEnergy restriction of 500 kcal/d and total Protein Uptake (including Supplementation) of 1.2 g/kg body mass/d |
| Energy restriction, walking and protein | Active comparator | Dietary Supplement: Protein, Behavioral: WalkingEnergy restriction of 250 kcal/d, increased energy consumption by walking (250 kcal/d) and total protein uptake (including supplementation) of 1.5 g/kg body mass/d |
| Energy restriction, walking, protein and WB-EMS | Active comparator | Dietary Supplement: Protein, Behavioral: Walking, Behavioral: WB-EMS applicationEnergy restriction of 250 kcal/d, increased energy consumption by walking (250 kcal/d), total protein uptake (including supplementation) of 1.5 g/kg body mass/d and WB-EMS application 1,5x 20 min/week |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- premenopausal women 25-50 years old
- overweight/obesity (body fat rate equal or higher 30%)
Key exclusion criteria (5 listed)
- medication and diseases affecting muscle and fat metabolism
- pregnant or parturition < 6 months
- any condition or medication that prevent proper physical activity or WB-EMS application
- holidays equal or more than 1 week during the intervention period
- other interventions with impact on the primary and core secondary outcome (i.e. body fat parameters) started during the last year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProteinProtein supplementation 1.2 or 1.5 g/kg body mass/d | Dietary supplement | Energy restriction, walking and protein, Energy restriction, walking, protein and WB-EMS, energy restriction and protein supplementation |
| WalkingWalking with a volume corresponding to 250 kcal/d | Behavioural | Energy restriction, walking and protein, Energy restriction, walking, protein and WB-EMS |
| WB-EMS applicationWB-EMS application 1.5x 20 min/week | Behavioural | Energy restriction, walking, protein and WB-EMS |
Primary outcome
Lean body mass
Time frame: changes from baseline to 16 week follow-up
Fat and bone free total body mass in kg
6 secondary outcomes
Total Body Fat
Time frame: changes from baseline to 16 week follow-up
Total Body Fat Rate
Time frame: changes from baseline to 16 week follow-up
Appendicular Skeletal Muscle Mass
Time frame: changes from baseline to 16 week follow-up
Visceral Body Fat
Time frame: changes from baseline to 16 week follow-up
Trunk fat
Time frame: changes from baseline to 16 week follow-up
Metabolic Syndrome Z-Score
Time frame: changes from baseline to 16 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon von Stengel, PhD study chair
Institute of Medical Physics, FAU Erlangen-Nürnberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein, Walking and WB-EMS application in people with Overweight and Obesity, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean body mass (time frame: changes from baseline to 16 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.